Thursday, May 26, 2016
Pfizer has announced results of two phase III studies demonstrating the immunogenicity of TRUMENBA (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe. The two studies, one in adolescents and one in young adults, met all primary immunogenicity endpoints. Also, secondary data presented show that TRUMENBA demonstrated similar immune responses against ten additional MnB strains, in both adolescents and young adults.
Veristat, a full service CRO, is expanding its clinical research offerings into Europe through the acquisition of U.K.-based CRO Spero Oncology. Spero Oncology specializes in providing clinical operations support for oncology clinical trials primarily throughout Europe, but also in Australia and New Zealand. With the acquisition of Spero Oncology, Veristat now offers its clients full clinical operations support in Europe including feasibility studies, legal representation in the European Union, clinical monitoring, project management, protocol writing and regulatory strategy.
GE Healthcare’s life sciences business has officially launched a new research scheme to help foster Turkish bioprocessing development and manufacturing, through its latest Fast Trak Bioprocessing Technology and Training Laboratory in Istanbul. Based in GE’s Turkey Innovation Center, the R&D Laboratory is well-located to support the region’s rapidly growing biopharmaceutical and biotech industry, and help position Turkey as a global R&D and manufacturing hub.
Civil servants must observe a period of “purdah” in the weeks before a general election or referendum, which restricts government activity to avoid unfairly influencing public opinion. This has hit two major consultations for the pharma industry—the Accelerated Access Review (AAR) and proposed changes to the medicines pricing system known as the Statutory Scheme. The AAR is the brainchild of life sciences minister George Freeman, who wants it to re-shape the U.K. market and the National Health Service (NHS) around encouraging medical innovation, and remove some of the blocks and bottlenecks which plague the current system.
The EMA has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).